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Bromfenac sodium hydrate eye drops and preparation method thereof

A technology of bromfenac sodium and hydrate, which is applied in the field of eye drops and its preparation, can solve problems such as eye irritation, instability in water, and instability of bromfenac sodium, and achieve low incidence of side effects and good healing effect Effect

Inactive Publication Date: 2013-03-27
娄飞
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, bromfenac sodium is unstable in water, and the preparation of bromfenac sodium into eye drops must first solve the problem of being unstable in water
However, if bromfenac sodium is too stable in water and stays in the eyes for a long time, it will cause greater irritation to the eyes.

Method used

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  • Bromfenac sodium hydrate eye drops and preparation method thereof
  • Bromfenac sodium hydrate eye drops and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Add 3000 g of water for injection into the concentrated preparation tank, and at the same time add 10.35 g of bromfenac sodium hydrate, 15 g of Tween 80, 2 g of disodium edetate, 20 g of anhydrous sodium sulfite, and 1 g of benzalkonium bromide, stir until uniform, and statically After standing for 30 minutes, it is filtered through a filter, and the filtrate is sent to the dilution tank;

[0017] Add 3000g of water for injection into the dilute tank, add 0.5g of boric acid, 0.5g of borax, and 200g of povidone at the same time, continue to add water to make up to 10000g, add sodium hydroxide to adjust the pH of the system to 8.0, and continue stirring for 20 minutes until the liquid is uniform ;

[0018] (3) Inspection, filter sterilization, potting, light inspection, packaging, full inspection, filter sterilization process uses a microporous membrane with a pore size of 0.45 μm.

Embodiment 2

[0020] Add 2000g of water for injection into the concentrated preparation tank, and at the same time add 10g of bromfenac sodium hydrate, 10g of Tween 80, 3g of disodium edetate, 40g of anhydrous sodium sulfite, and 2g of benzalkonium bromide, stir until uniform, and let stand After 40 minutes, filter through the filter, and the filtrate is sent to the dilution tank;

[0021] Add 3000g of water for injection into the dilute preparation tank, add 1g of boric acid, 2g of borax, and 400g of povidone at the same time, continue to add water to make up to 10000g, add sodium hydroxide to adjust the pH of the system to 8.4, and continue stirring for 20 minutes until the liquid medicine is uniform;

[0022] (3) Inspection, filter sterilization, potting, light inspection, packaging, full inspection, filter sterilization process uses a microporous membrane with a pore size of 0.22 μm.

Embodiment 3

[0024] Add 2500g of water for injection into the concentrated preparation tank, add 20g of bromfenac sodium hydrate, 30g of Tween 80, 2g of disodium edetate, 50g of anhydrous sodium sulfite, and 1g of benzalkonium bromide, stir until uniform, and let stand After 60 minutes, filter through the filter, and send the filtrate to the dilution tank;

[0025] Add 2500g of water for injection into the dilute preparation tank, add 2g of boric acid, 1.5g of borax, and 100g of povidone at the same time, continue to add water to make up to 10000g, add sodium hydroxide to adjust the pH of the system to 8.6, and continue stirring for 20 minutes until the liquid medicine is uniform;

[0026] (3) Inspection, filter sterilization, potting, light inspection, packaging, full inspection, filter sterilization process uses a microporous membrane with a pore size of 0.22 μm.

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Abstract

The invention discloses eye drops and a preparation method thereof, and particularly relates to bromfenac sodium hydrate eye drops and a preparation method thereof. The bromfenac sodium hydrate eye drops comprise the following constituents in percentage by weight: 0.1-0.2% of bromfenac sodium hydrate, 0.1-0.3% of Tween-80, 1-5% of povidone, 0.01-0.03% of edetate disodium, 0.2-0.5% of anhydrous sodium sulfite, 0.01-0.02% of benzalkonium bromide, 0.005-0.02% of boric acid, 0.005-0.02% of borax, 0.002-0.01% of sodium hydroxide, and the balance of water.

Description

Technical field: [0001] The invention relates to an eye drop and a preparation method thereof, in particular to bromfenac sodium hydrate eye drop and a preparation method thereof. Background technique: [0002] Bromfenac sodium is a derivative of 2-amino-3-benzoylphenylacetic acid, which has anti-inflammatory and analgesic effects. Pharmacological experiments show that bromfenac sodium has anti-inflammatory effect on rat experimental acute conjunctival edema induced by arachidonic acid and carrageenan; almost completely inhibits the expression of aqueous humor protein induced by laser irradiation after anterior chamber puncture in rabbits. Concentration increases. But bromfenac sodium is unstable in water, and bromfenac sodium is prepared into eye drops at first to solve the problem of being unstable in water. However, if bromfenac sodium is too stable in water and stays in the eyes for a long time, it will cause greater irritation to the eyes. Invention content: [000...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/196A61K47/32A61P27/02
Inventor 娄飞
Owner 娄飞
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